MRI Contrast Agents Draw Warning | WSJ | 5.24.07
WASHINGTON — The Food and Drug Administration said it is asking manufacturers of certain contrast agents used in patients undergoing magnetic resonance imaging, or MRI, scans to place a black-box warning on the agents’ packaging.
The FDA said the warning, which would apply to five gadolinium-based contrast agents — including ones made by General Electric Co.’s health-care unit and a Bayer AG unit — would state that patients with severe kidney insufficiency are at risk of developing a debilitating and potentially fatal disease known as nephrogenic systemic fibrosis, or NSF. A black-box warning is the FDA’s strongest drug warning.
See also:
- FDA’s Questions and Answers on Gadolinium-Based Contrast Agents
- eMedicine on Nephrogenic Fibrosing Dermopathy (NFD) (also known as nephrogenic systemic fibrosis, NSF)
The gadolinium-based contrast agents now join the CT contrast agents in terms of potential complications. Looks like the ED consent forms for contrast now need to include the GBCA warnings for those “emergent” MRAs.